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FDA 510(k)

切除電極

K 號:K161600 · 2016-09-06

決定日期2016-09-06
產品代碼JOS
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Resection Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161600. The device is classified under product code JOS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Resection Electrodes?

Resection Electrodes is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K161600.

When did Resection Electrodes receive FDA 510(k) clearance?

Resection Electrodes received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161600.

Who is the listed applicant for Resection Electrodes?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resection Electrodes?

The FDA product code for Resection Electrodes is JOS.

相關臨床試驗

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其他以 Olympus Winter & Ibe GmbH 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

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